Edwards Lifesciences (NYSE:EW) said yesterday that data from the 1st 13 uses of its Forma transcatheter tricuspid repair system reported no deaths or major complications.
The announcement was made at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco and data from the 1st 7 patients was published in the Journal of the American College of Cardiology.
The Forma system is designed to occupy the regurgitant orifice area to provide a surface for the coaptation of the valves native leaflets to reduce triuspid regurgitation, Edwards said.
“Moderate-to-severe tricuspid regurgitation is present in an estimated 1.6 million Americans1, yet isolated tricuspid valve surgery is extremely rare. Severe TR is an under-recognized and under-treated condition, and it is associated with a poor prognosis. We are encouraged by our early experience with the Forma system in which a valuable finding was that patients had positive changes in their symptoms and quality of life. We look forward to further study to learn if an isolated tricuspid transcatheter treatment can improve the prognosis for patients with severe TR,” Dr. Josep Rodes-Cabau of Quebec’s Heart & Lung Institute at Laval University said in prepared remarks.
Investigators found that 12 of the 13 patients were successfully implanted with the system, and said that the system “appears safe and feasible” as TR reduction was observed in the implanted patients, according to Edwards.
Investigators added the caveat that a longer-term follow-up and larger studies would be rquired to confirm the preliminary results.
Here’s some other news coming out of the annual Transcatheter Cardiovascular Therapeutics conference:
Stents: Restinosis study of Boston Scientific’s Taxus, Cordis’ Cypher returns positive results
Stents: Abbot’s Absorb III data is good, but “not a home run” according to Leerink analysis
Stents: Amaranth completes CE studies for Fortitude drug-eluting bioresorbable scaffold
Stents: Study of Biosensor’s BioFreedom shows reduced need for repeat revascularization
Stents: Abbott’s Xience shows promise for Type 2 diabetes patients, study reports
Stents: Reva presents data from study of its Fantom drug eluting stent
Stents: Elixir Medical releases results from 3-year study of DEsolve stent
Stents: Siromed’s BuMA SES found noninferior to Miomatrix’ Excel SES
TAVR: Claret Medical says study of Sentinel CPS reports neurocognitive benefits
TAVR: Keystone Heart touts study showing its Neuro TAVR device reduces brain lesions
DCB: Biotronik touts study of Pantera Lux in treating in-stent restinosis
LAA: Study of growing device field shows promise in improving safety, outcomes
MVR: Study of Harpoon Medical’s mitral regurgitation repair system returns 100% success, survival
The post TCT 2015 Roundup: Edwards presents early Forma tricuspid repair results appeared first on MassDevice.
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